Sirona Orthophos SL Maintenance manual

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Sirona Dental Systems GmbH
Maintenance Instructions ORTHOPHOS SL 2D / 3D
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Sirona Dental Systems GmbH Table of contents
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Table of contents

1
2
3
4
5
6
7
8
9
10
11
Safety ...................................................................................................................... 4
Operation notes....................................................................................................... 5
Auxiliary devices required........................................................................................ 6
Visual check ............................................................................................................ 7
Optical and acoustic signals.................................................................................... 8
5.1 Checking the function of keys and buttons................................................... 9
Checking the power supply connection................................................................... 11
Checking the tube current ....................................................................................... 13
Checking the tube voltage....................................................................................... 17
Checking the radiation time..................................................................................... 18
Checking the laser light localizers ........................................................................... 19
Test exposures/Test images ................................................................................... 22
11.1 Calling "Test exposures" menu .................................................................... 23
11.2 2D test exposures ........................................................................................ 24
11.2.1 Pan - diaphragm test exposure (2D) ............................................... 24
11.2.2 Pan - Symmetrical test exposure (2D) ............................................ 25
11.2.3 Pan - quality test exposure (2D)...................................................... 26
11.2.4 Pan - test image (2D) ...................................................................... 28
11.2.5 Pan - dark current exposure (2D).................................................... 30
11.2.6 Ceph - secondary diaphragm (2D).................................................. 32
11.2.7 Ceph - quality test exposure (2D).................................................... 33
11.2.8 Ceph - test image (2D) .................................................................... 36
11.3 3D test exposures ........................................................................................ 38
11.3.1 Diaphragm test exposure (open) (3D)............................................. 38
11.3.2 Diaphragm test exposure (collimated) (3D)..................................... 40
11.3.3 Diaphragm test exposure (standard) (3D)....................................... 42
11.3.4 Quality test exposure (3D)............................................................... 44
11.3.5 Test image (3D)............................................................................... 46
11.3.6 Dosimetry (3D) ................................................................................ 48
11.3.7 Quality control 21CFR 1020.33 (3D)............................................... 49
Yearly maintenance checklist.................................................................................. #?
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3
1Safety Sirona Dental Systems GmbH
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Safety

1
NOTICE
Qualifications of service personnel
Installation and startup may be carried out only by personnel specifically authorized by Sirona.
WARNING
Perilous shock hazard!
You must switch off the unit and then wait at least 1 minute, for measurements at the tube assembly at least 4 minutes, before you start to connect test cables or remove a cover! For measurements in the area of the power supply terminal, the unit must be disconnected from the junction box of the building installation before you start to connect test cables!
DANGER
X-rays
When performing the following tests, be sure to observe the radiation protection regulations applicable in your country (see Operating Instructions).
DANGER
X-rays
"Radiation" is signaled by the message "X-RAY active!", a beep, and an X-ray LED.
NOTICE
Risk of damage to boards
Please observe the usual precautionary measures for handling printed circuit boards (ESD). Touch a ground point to discharge static electricity before touching any boards.
IMPORTANT
It is essential that you also observe the notes about the operation of the unit in the Operating Instructions.
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Sirona Dental Systems GmbH 2Operation notes
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Operation notes

2
Nominal line voltage The unit operates in the following nominal line voltage ranges:
● 200 – 240 V
●50/60Hz
The permissible line voltage fluctuation is ±10%.
The internal line impedance must not exceed 0.8 Ω.
Only permanent electrical connection of the unit is allowed.
IMPORTANT
The regulation "Federal Performance Standard for Diagnostic X-ray Units, Code of Federal Regulations, Title 21 CFR, Subchapter J" requires a corresponding power supply connection.
Cooling period The cooling period between two exposures is maintained by an automatic
exposure blocking function according to the pulse/pause ratio (see Operating Instructions). The decrementing waiting time count is displayed on the control panel.
Measurements Always switch the unit off before connecting a measuring instrument.
For safety reasons, the power supply should be switched off at the junction box of the building installation when performing measurements in the vicinity of the power supply unit.
Select the correct current/voltage type and adjust the measuring range to match the expected readings.
Perform continuity tests only on units which are switched off.
If several exposures with radiation must be taken to check a measurement, make sure that the prescribed cool-down intervals are observed. They are maintained by an automatic exposure blocking function (see Operating Instructions).
The pulse/pause ratio is 1:20, i.e. a 20-second pause is maintained for each second of radiation cycle. The pulse/pause ratio is automatically maintained (automatic exposure blocking).
It is essential that you observe the radiation protection regulations applicable in your country prior to radiation release.
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3Auxiliary devices required Sirona Dental Systems GmbH
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Auxiliary devices required

3
Digital multimeter USA
CAUTION
Only use a battery-operated digital multimeter with safety sockets. It is essential that you observe the safety and operating notes provided in the operating instructions of the multimeter.
● Battery-operated digital multimeter of type:
– Fluke 8000 A
– Philips PM 2816 rms
– or similar
Dosimeter USA
CAUTION
It is essential that you observe the safety and operating notes provided in the operating instructions of the dosimeter.
● Dosimeter for pulsed radiation of type:
– Mult-O-Meter 512L
– or similar
Measuring wires
CAUTION
Use exclusively fully insulated measuring wires. Check the measuring wires for damages before use.
● Measuring wires with the following properties:
– dielectric strength > 1000V
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Sirona Dental Systems GmbH 4Visual check
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Visual check

4
● Check for mechanical damage that could affect radiation protection.
● Check that all labels are attached and legible.
– Damaged/imperfect labels must be replaced.
You can order them in writing from Sirona (see back page for address), stating the following:
– Customer's name
– Customer's address
● Check to see whether all model numbers and serial numbers must still be legible on the unit so that it can be identified.
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5Optical and acoustic signals Sirona Dental Systems GmbH
A
C
B
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Optical and acoustic signals

5
XG 3D optical and acoustic signals
1. Turn the main switch (A) to position I.
ª The X-Ray radiation indicator C lights up briefly.
ª After approx. 2 seconds, the green LED B in the upper part of the
control panel lights up. This LED remains lit as long as the unit is on.
ª The start screen appears on the touchscreen of the Easypad and
the initialization of the device starts running (for approx. 1 minute). The rotating element rotates briefly clockwise and counterclockwise. The diaphragm moves into position. The forehead and temple supports on the panoramic unit open and close and then stop moving in fully opened position.
2. Check the function of the keys.
ª Press a height-adjustment key. The movement of the height-
adjustment motor is accompanied by an acoustic signal.
ª Press the keys for adjusting the forehead support and the temple
support. If the keys are working correctly, the supports stop automatically when they come into contact with the patient's head.
ª If Remote has been installed, test the buttons and the display of
the remote unit, too.
ª The release button must not be defective or damaged.
See also the Operating Instructions, in the Operation section.
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Sirona Dental Systems GmbH 5Optical and acoustic signals
A
B C
Ready for exposure
D E F
Maintenance Instructions ORTHOPHOS SL 2D / 3D 5.1Checking the function of keys and buttons
5.1

Checking the function of keys and buttons

Radiation protection measures
WARNING
The unit emits X-ray radiation.
Excess exposure to X-rays is detrimental to health.
➢ Use the prescribed accessories for radiation protection.
➢ Do not stay in the X-ray room during exposure. Move as far away
from the unit as the coiled cable for the release button allows you to.
"Unit ON" LED display C lights up. Press the R key D to move the unit
to the starting position. As long as no connection has been made to SIDEXIS, the message is displayed in the comment line of the control panel on the touchscreen.
1. Switch on the PC.
2. Start SIDEXIS (see SIDEXIS user manual). For further information and possible error messages, see Operating Instructions.
3. Use the -/+ keys to select a program E.
4. In the sub menu F, select a kV/mA combination with the -/+ keys.
5. Check whether the patient symbols on the touchscreen can be selected in exactly the right position. If problems occur during selection, adjust the touchscreen).
6. Press release button (A) and hold it down until the end of the exposure.
ª The exposure is released.
the comment line on the touchscreen. During radiation, the optical radiation indicator (B) lights up on the Easypad; during radiation, an acoustic signal is also emitted. Radiation can be triggered multiple times during exposure. When the rotation and radiation switch off automatically, the exposure is complete.
"Switch SIDEXIS to ready for exposure state"
"Exposure is performed"
Appears in
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7. Let go of release button (A). ª The exposure is completed.
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5Optical and acoustic signals Sirona Dental Systems GmbH
5.1Checking the function of keys and buttons Maintenance Instructions ORTHOPHOS SL 2D / 3D
8. Cancel exposure - Check deadman function Select the same exposure parameters. The operational readiness LED B flashes until the automatic cooling­off period of the X-ray tube assembly has expired (automatic exposure block).
9. Press the release button A.
10. Let go of the exposure release button. ª The exposure is immediately terminated.
The confirmation of the exposure data is displayed on the touchscreen. The radiation time and the area dose product (the lower two values) flash. In this way, an exposure that has been triggered can be canceled again at any time.
CAUTION
Defective indicators and keys represent a risk to the safety of both the patient and the operator.
The user is not permitted to operate the unit until the necessary repairs have been made.
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Sirona Dental Systems GmbH 6Checking the power supply connection
K1
K1
300V
AC
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Checking the power supply connection

6
To check the line voltage, the creating an X-ray. To do this, proceed as follows:
Preparing the measurement
1. DANGER! After disconnecting the unit from the junction box of the building installation, wait at least 1 minute before starting to check the line voltage! Disconnect the unit from the junction box of the building installation.
2. Remove the "Bottom profile" cover (see Service Manual).
line voltage drop
must be determined while
3. CAUTION! Only use fully insulated measuring wires. Connect the measuring wires as shown in the illustration to the connectors L and N of the power supply terminal K1.
4. On the multimeter, select the voltage measuring range "300 V
5. Re-attach the unit to the junction box of the building installation.
6. DANGER! Do not touch any live components! Set the main switch (A) to I (see also Operating Instructions).
7. Wait for approx. 1 minute.
8. Press the R key. ª The unit moves to its starting position.
Performing and analyzing a measurement
1. Set the highest kV/mA level, e.g. 90kV/ 12mA (see Operating Instructions).
2. Make ready for exposure in SIDEXIS.
3. CAUTION! Activating the release button triggers X-rays. Activate the release button and take the voltage drop reading on the multimeter display.
ª If the measured voltage drop does
tolerance range
a suitable line voltage (according to the notes listed in the Installation Requirements) must be installed.
(see the following table), notify the customer that
not fall within the permissible
AC
".
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6Checking the power supply connection Sirona Dental Systems GmbH
Maintenance Instructions ORTHOPHOS SL 2D / 3D
IMPORTANT
In such a case, the unit must be switched off immediately and disconnected from the junction box of the building installation. It must not be placed in operation!
ª If the measured voltage drop falls within the permissible
tolerance range (see the following table), finalize the measurement.
Permissible voltage drop:
Line voltage, with zero load Max. permissible
line voltage drop
180-208 V 9 V
208-230 V 8 V
230-240 V 7.5 V
240-264 V 7 V
Concluding the measurement
1. Switch the unit on via switch (A) (see also Operating Instructions).
2. Disconnect the unit from the junction box of the building installation.
3. DANGER! Wait at least 1 minute after disconnecting the unit from the junction box of the building installation before removing the measuring wires! Remove the measuring units from the unit.
4. Re-attach the "Bottom profile" cover to the unit.
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Sirona Dental Systems GmbH 7Checking the tube current
E
D
G
F
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Checking the tube current

7
NOTICE
Damage to the measuring unit
The ring assembly and the tube assembly move during the measurement. Make sure that the measuring wires are sufficiently long to allow for the ring movement and that the measuring unit is in a secure position so that it will not fall down.
Preparing the measurement
1. Switch off the unit (see Operating Instructions). DANGER! After switching off the unit, wait at least 4 minutes (LED V500 on the DX6 must no longer be on) before removing the cover on the tube assembly.
2. Loosen the screw (D) and remove the lid of the tube assembly cover (E).
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3. Loosen the 4 screws (F) and remove the cover plate (G).
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7Checking the tube current Sirona Dental Systems GmbH
Maintenance Instructions ORTHOPHOS SL 2D / 3D
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Sirona Dental Systems GmbH 7Checking the tube current
E
D
Maintenance Instructions ORTHOPHOS SL 2D / 3D
4. DANGER! After switching off the unit, wait at least 4 minutes (LED V500 on the DX6 must no longer be on) before removing jumper H from the DX6 board. Remove the jumper (H) from connector X302 on the DX6 board.
5. DANGER! Only use fully insulated measuring wires. Connect the digital multimeter with the measuring wires to test points MA- (X5-) and MA+ (X4+) at connector X302 on the DX6 board.
6. On the multimeter, select the current measuring range 20mA DC.
7. NOTICE! If the lid of the tube assembly cover is not attached, the ring circulation is impeded and the unit can be damaged. Temporarily install the lid of the tube assembly cover (E) on the unit using the screw (D).
8. DANGER! Do not touch any live components! Set the main switch (A) to I (see also Operating Instructions).
9. Wait for approx. 1 minute.
10. Touch the R key on the touchscreen. ª The unit moves to its starting position.
Performing measurements
1. Select the P1 program (see Operating Instructions).
2. Set the highest kV/mA level, 66kV /8mA (see Operating Instructions).
3. Establish readiness for exposure (see SIDEXIS 4 Operator´s Manual).
4. CAUTION! Activating the release button triggers X-rays. Start the exposure by pressing the release button. Hold down the release button until image acquisition is completed and the acoustic signal that indicates the end of the exposure can be heard.
IMPORTANT
1 mA corresponds to a tube current of 1 mA. The permissible tolerance is ± 20 %.
Analyzing measurements
➢ Read the voltage value on the display of the multimeter.
ª The tube current must be 8mA ± 1.6mA.
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ª If the measured value is
replace the
ª If the measured value falls within the permissible tolerance,
conclude the measurement.
tube assembly
not
within the permissible tolerance,
.
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7Checking the tube current Sirona Dental Systems GmbH
E
DGF
E
D
Maintenance Instructions ORTHOPHOS SL 2D / 3D
Concluding the measurement
1. Switch the unit on via switch (A) (see also Operating Instructions).
2. Loosen the screw (D) and remove the lid of the tube assembly cover (E).
3. DANGER! After switching off the unit, wait at least 4 minutes before removing the measuring wires or reinserting the jumper! Remove the measuring wires and bridge with the test points MA+/ MA- on the DX6 board again with the jumper (H).
4. Reattach the cover plate (G) to the tube assembly with the 4 screws (F).
5. Reattach the lid of the tube assembly cover (E) to the unit and secure it with the screw (D).
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Sirona Dental Systems GmbH 8Checking the tube voltage
A
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Checking the tube voltage

8
Preparing the measurement
1. Attach the Mult-O-Meter sensor in the middle of the sensor (on 2D sensor side).
2. Set the main switch (A) to I (see also Operating Instructions).
3. Wait for approx. 1 minute.
4. Touch the R key on the touchscreen. ª The unit moves to its starting position.
Performing measurements
1. Select the P1 program (see Operating Instructions).
2. Set the kV/mA level 63kV/ 8 mA (see Operating Instructions).
3. Establish readiness for exposure (see SIDEXIS 4 Operator´s Manual).
4. CAUTION! Activating the release button triggers X-rays. Start the exposure by pressing the release button. Hold down the release button until image acquisition is completed and the acoustic signal that indicates the end of the exposure can be heard.
Analyzing measurements
➢ Read the voltage values on the display of the Mult-O-Meter.
IMPORTANT
The measured tube voltage must correspond with the tube voltage set of 63kV. The permissible tolerance is ± 10 %.
ª If the measured values
, replace the
range
ª If the measured values are within the permissible tolerance
range, finalize the measurement.
are not within the permissible tolerance
tube assembly
.
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Concluding the measurement
➢ Switch the unit on via switch (A) (see also Operating Instructions).
17
9Checking the radiation time Sirona Dental Systems GmbH
A
Maintenance Instructions ORTHOPHOS SL 2D / 3D

Checking the radiation time

9
Preparing the measurement
1. Attach the Mult-O-Meter sensor in the middle of the combisensor (on 2D sensor side).
2. Set the main switch (A) to I (see also Operating Instructions).
3. Wait for approx. 1 minute.
4. Press the R key. ª The unit moves to its starting position.
5. Call the Service menu and the Service routine S002.3 (see Service Manual).
6. Use the arrow keys (A) in 60 kV/8 mA.
7. Use the arrow keys (A) in
0.5 s.
selection field 1
selection field 2
to select the kV/mA level
to select the radiation time
Performing measurements
➢ Initiate the radiation. Hold the release button pressed until the set
radiation time has expired.
Analyzing measurements
➢ Read the radiation time on the Mult-O-Meter.
ª The value for the radiation time displayed on the Mult-O-Meter
must correspond to the radiation time of 0.5s selected in the service routine. The permissible tolerance is ± 10 %.
ª If the measured radiation time does
tolerance, replace the
ª If the measured radiation time falls within the permissible
tolerance, finalize the measurement.
Concluding the measurement
1. Exit the service routine.
2. Switch the unit on via switch (A) (see also Operating Instructions).
tube assembly
not
fall within the permissible
(see Service Manual).
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Sirona Dental Systems GmbH 10Checking the laser light localizers
Maintenance Instructions ORTHOPHOS SL 2D / 3D
10

Checking the laser light localizers

CAUTION
Risk of injury to eyes.
The unit contains lasers of Class 1. Keep a distance of at least 4" (10 cm) between eye and laser. Do not look into the laser beam.
Checking the laser light localizers
Preparing the test
1. Insert the forehead and temple supports.
2. Set the main switch (A) to I (see also Operating Instructions).
3. Wait for approx. 1 minute.
4. Touch the R key on the touchscreen.
ª The unit moves to its starting position.
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